Loxotop Special Precautions

WARNING: Risk of GI Ulceration, Bleeding and Perforation with NSAID: Serious GI toxicity such as bleeding, ulceration and perforation can occur at any time, with or without warning symptoms, in patients treated with NSAID therapy. Although minor upper GI problems (e.g. dyspepsia) are common, usually developing early in therapy, prescribers should remain alert for ulceration and bleeding in patients treated with NSAIDs even in the absence of previous GI tract symptoms.
Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Patients with prior history of serious GI events and other risk factors associated with peptic ulcer disease (e.g. alcoholism, smoking, and corticosteroid therapy) are at increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less than other individuals and account for most spontaneous reports for fatal GI events.
Careful Administration: LOXOTOP PAP 100 mg Patch should be administered with caution in the following patients: Patients with bronchial asthma (as the disease state may be exacerbated).
Important Precautions: It is important to note that treatment with anti-inflammatory-analgesic agents is a symptomatic treatment, not a causal treatment.
For treatment of skin inflammation caused by infectious disease, LOXOTOP PAP 100 mg Patch may cause a risk of masking the signs and symptoms of the infectious disease, therefore, the appropriate antibacterial and/or antifungal drugs must be administered in combination with LOXOTOP PAP 100 mg Patch to the affected part of the skin, under careful observation and caution.
Therapies other than drug treatment must also be considered in using LOXOTOP PAP 100 mg Patch in the management of chronic diseases (osteoarthritis and others). The patient's clinical condition should be closely monitored with caution against the development of adverse reactions.
Precautions Concerning Use: Site of application: Do not apply LOXOTOP PAP 100 mg Patch onto area of damaged or non-intact skin or mucosal membrane.
Do not apply LOXOTOP PAP 100 mg Patch onto area of eczema and rash.
Effects on Ability to Drive and Use Machines: There is no data available on effects on ability to drive and use machines.
Use in Children: The safety of LOXOTOP PAP 100 mg Patch in low birth weight infants, newborn infants, infants and toddlers, children and adolescents has not been established (because there has been little experience of its use in pediatric patients).
Use in the Elderly: LOXOTOP PAP 100 mg Patch should be used with careful monitoring of dermal condition of application area, in the elderly patients.